Pharmaceutical Quality Director – Mexico

Hunters Group; Estado de México; On-site; MXN 2,400,000 - 4,200,000; Full time

Job summary

Hunters Group seeks an experienced Pharmaceutical Quality Director to lead QA, QC and regulatory compliance for its manufacturing operations in Mexico.

You will ensure GMP compliance, product integrity, inspection readiness and continuous improvement, directing diverse quality teams and coordinating with senior leadership.

Qualifications

• Bachelor's degree in Pharmaceutical Chemistry, Pharmacy, Chemistry, or related field.
• Advanced degree preferred.

Responsibilities

• Lead Quality Assurance, Quality Control, and Quality Systems.
• Ensure compliance with COFEPRIS, NOM-059, GMP, and applicable international regulatory standards.
• Oversee batch release processes, manufacturing deviations, investigations, and CAPA programs.
• Lead regulatory inspections and corporate quality audits.
• Manage product quality risks, validation programs, and contamination control.
• Direct quality teams, laboratories, and compliance initiatives.
• Maintain inspection readiness and ensure product supply continuity.
• Report directly to senior executive leadership.

Skills

Quality leadership

GMP compliance

COFEPRIS knowledge

Regulatory inspections

Team leadership

Education

Bachelor's degree in Pharmaceutical Chemistry, Pharmacy, Chemistry, or related field

Advanced degree preferred

Job description

Pharmaceutical Quality Director – Mexico

HUNTERS GROUP

Location: Mexico City / State of Mexico

Industry: Pharmaceutical Manufacturing / Life Sciences

Level: Executive Management

Position Overview

We are seeking an experienced Pharmaceutical Quality Director to lead quality assurance, quality control, and regulatory compliance for a major pharmaceutical manufacturing operation in Mexico.

The successful candidate will ensure manufacturing compliance, product integrity, regulatory readiness, and continuous improvement across pharmaceutical production facilities.

Key Responsibilities

• Lead Quality Assurance, Quality Control, and Quality Systems.
• Ensure compliance with COFEPRIS, NOM-059, GMP, and applicable international regulatory standards.
• Oversee batch release processes, manufacturing deviations, investigations, and CAPA programs.
• Lead regulatory inspections and corporate quality audits.
• Manage product quality risks, validation programs, and contamination control.
• Direct quality teams, laboratories, and compliance initiatives.
• Maintain inspection readiness and ensure product supply continuity.
• Report directly to senior executive leadership.

Qualifications

• Bachelor's degree in Pharmaceutical Chemistry, Pharmacy, Chemistry, or related field.
• Advanced degree preferred.
• 12+ years of experience in pharmaceutical manufacturing and quality management.
• Minimum 5 years in senior quality leadership.
• Extensive knowledge of GMP, NOM-059, COFEPRIS, and pharmaceutical validation.
• Proven experience managing regulatory inspections and quality audits.
• Strong leadership of multidisciplinary technical teams.